Efficacy and Safety Study of ABT-436 in Major Depressive Disorder

Stopped early · Phase 2 · Has a placebo group

Conditions studied: Major Depressive Disorder

In brief

The purpose is to study the efficacy and safety of ABT-436 in Major Depressive Disorder.

Key facts

Study ID

NCT01741142

Run by

AbbVie (prior sponsor, Abbott)

People needed

19

Starts

2012-01-01

Expected to finish

2015-08-01

Last updated by the study team

2013-10-08

Who can join

Age: 18 and older, up to 65. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Has a primary Diagnostic and Statistical Manual of Mental Disorders-Fourth Edition-Text Revision diagnosis of major depressive disorder without psychotic features
• No current antidepressant treatment within 7 half-lives or 2 weeks, whichever is longer, prior to Day minus 1.
• Can safely be treated on an outpatient basis.
• A condition of general good physical health.
• Surgically sterile, using a highly effective method of birth control or (if female) at least 1 year post menopausal.

You may not qualify if…

• History of hypersensitivity, intolerance or adverse reaction to escitalopram that led to discontinuation, or hypersensitivity to citalopram. History of serotonin syndrome.
• Inadequate response to more than two different antidepressant medications during the current major depressive episode.
• History of electroconvulsive therapy, vagal nerve stimulation or deep brain stimulation.
• History of transcranial magnetic stimulation during the current major depressive episode.
• Psychotherapy that has not been ongoing for at least 3 months prior to Day minus 1.

Where it is running

• Site Reference ID/Investigator# 85593 — Little Rock, Arkansas, United States
• Site Reference ID/Investigator# 87228 — Garden Grove, California, United States
• Site Reference ID/Investigator# 87214 — National City, California, United States
• Site Reference ID/Investigator# 87220 — Oakland, California, United States
• Site Reference ID/Investigator# 87215 — Bradenton, Florida, United States
• Site Reference ID/Investigator# 87225 — South Miami, Florida, United States
• Site Reference ID/Investigator# 85594 — Atlanta, Georgia, United States
• Site Reference ID/Investigator# 85580 — Marlton, New Jersey, United States
• Site Reference ID/Investigator# 87227 — Brooklyn, New York, United States
• Site Reference ID/Investigator# 87223 — New York, New York, United States
• Site Reference ID/Investigator# 87217 — Dayton, Ohio, United States
• Site Reference ID/Investigator# 87226 — Portland, Oregon, United States
• Site Reference ID/Investigator# 87221 — Philadelphia, Pennsylvania, United States
• Site Reference ID/Investigator# 87219 — Austin, Texas, United States
• Site Reference ID/Investigator# 87216 — Dallas, Texas, United States
• Site Reference ID/Investigator# 87933 — Houston, Texas, United States
• Site Reference ID/Investigator# 88874 — Salt Lake City, Utah, United States
• Site Reference ID/Investigator# 88876 — Seattle, Washington, United States

Full record on ClinicalTrials.gov

Trial information comes from ClinicalTrials.gov and is refreshed daily. TrialsForMe does not provide medical care and does not run the studies it lists.